Kornimate/medical-research-clean huggingface dataset:
cleanoze® irrigation device with powder preparation versus conventional irrigation method for chronic rhinitis

Conditions: Rhinitis

Summary: the investigators proposed that the cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. this study will compared the efficacy, adverse reactions, complications and ease of use of cleanoze® comparing with normal saline solution

cleanoze® consists of a powder made up of sodium chloride and sodium bicarbonate. this powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. this fluid is isotonic solution. the nasal saline irrigation is the common procedure for upper respiratory tract infection patients including chronic rhinitis. the physician usually order the normal saline with appropriate medication e.g. anti-histamines, nasal steroids and anti-biotics to treat this condition. the investigators proposed that the cleanoze® is superior to the traditional nasal saline irrigation in term of the ease of use which will resulting in a better quality of life of the participants. this study will compared the efficacy, adverse reactions, complications and ease of use of cleanoze® comparing with normal saline solution. study population: any patients with chronic rhinitis (e.g. allergic rhinitis, vasomotor rhinitis) will be randomized to receive the study or control medication. the investigators will include the children 5 years and above which able to doing the lavage under the parents assistant or by them self. study design: phase iii randomized controlled trial sample size: estimate from pilot study, the 71 patients per arm was estimated (142 participants totally). study duration: * duration of enrollment is 1 year. * the patients will be followed up to 1 months depend on the disease conditions. * the data analysis will take 3 additional months * the full report will complete after the data analysis within 3 months * the total of 1 year and 6 months period needed for this study. primary objective: to compare the satisfaction of the patients using cleanoze® versus conventional device secondary objective(s): * the adherence to cleanoze® device * the durability of the cleanoze® device * the patient symptom score (vas) * the snot-22 questionaire for evaluating the quality of life of the patients

Eligibility criteria:
inclusion criteria: * any patients with chronic rhinitis conditions regardless of any cause (e.g. allergic, irritant, infection) exclusion criteria: * acute or chronic rhinosinusitis * acute nasopharyngitis (common cold) * patients with a tendency to aspirate such as cerebrovascular accident, cranio-facial diseases. * sinunasal, nasopharyngeal and skull base tumors * age under 5 years old. * cannot administer a saline irrigation under the assistant of a care giver.

Keywords: rhinitis
study of genetic and molecular defects in primary immunodeficiency disorders

Conditions: X-Linked Agammaglobulinemia; X-Linked Hyper IgM Syndrome; Wiskott-Aldrich Syndrome; Leukocyte Adhesion Deficiency Syndrome

Summary: objectives: i. identify the molecular defects responsible for primary immunodeficiency disorders. ii. explore the mutations within each syndrome to better understand the genetics of these disorders. iii. study the function of the wiskott-aldrich syndrome proteins (wasp). iv. design methods to identify carriers and for prenatal diagnosis. v. explore new avenues for therapy.

protocol outline: patients are studied systematically to determine the extent of their immune deficiency and to confirm a specific diagnosis. patients with a known immunodeficiency syndrome are studied in detail to identify the gene mutation, to assess the effect of the mutation on the gene product, and to establish cell lines for further in vitro assessment of the genetic defect. the function of wiskott-aldrich syndrome proteins (wasp) in hematopoietic cells is studied. family members of patients with x-linked disorders are studied to identify carrier females.

Eligibility criteria:
protocol entry criteria: primary immunodeficiency disease, e.g.: leukocyte adhesion deficiency syndrome wiskott-aldrich syndrome x-linked agammaglobulinemia x-linked hyper igm syndrome

Keywords: wiskott-aldrich syndrome x-linked agammaglobulinemia x-linked hyper igm syndrome genetic diseases and dysmorphic syndromes immunologic disorders and infectious disorders leukocyte adhesion deficiency syndrome primary immunodeficiency disease rare disease
comparing 3 antibiotic regimes for erythema migrans in general practice

Conditions: Erythema Migrans; Erythema Chronicum Migrans; Borreliosis; Lyme Disease; Early Lyme Disease

Summary: tick borne diseases are increasing in norway. lyme borreliosis is the most common infection. erythema migrans is mainly diagnosed and treated in general practice. there is disagreement about what antibiotic treatment that should be given. an rct with the three most common antibiotics used, will support data for revision of national guidelines.

comparison of phenoxymethylpenicillin, doxycycline and amoxicillin for erythema migrans in norwegian general practice. every patient receives 14 days of antibiotic treatment. there are blood samples for measurement of borrelia antibody level at day 1, 14 and 90 and questionnaires on subjective health complaints (shc) at day 1, 90 and 360. side symptoms and side effects are registered. for volunteers there is an additional pcr-analysis on punch biopsy from the em for subgrouping of the borrelia bacteria. tbe-antibodies are measured on day 14. antibody levels and shc-scores are compared to healthy blood donors.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of erythema migrans * over the age of 18 * signing an concent form after information in writing exclusion criteria: * allergic to any of the three drugs in the study * under the age of 18 * pregnancy * dementia or known drug abuse * antibiotic treatment last 14 days * concommitant chemotherapy or immunomodulating therapy * concommitant use of medicine with potential interaction (defined in protocol)

Keywords: antibiotics general practice erythema migrans borrelia ticks
use of diagnostic dye to identify areas of leakeage,in the retina, prior to receiving focal laser treatment

Conditions: Macular Edema

Summary: the use of indocyanine green diagnostic dye will identify areas of vascular leakage which will provide more effective laser treatment by targeting these specific areas.

the early treatment of diabetic retinopathy study showed that early treatment of clinically significant macular edema (csme) with focal and grid laser preserved vision in diabetic patients. indocyanine green angiography, which was not available at the time of the early treatment diabetic retinopathy study (etdrs), is now standard-of-care for diagnostic evaluation of the choroidal circulation and is routinely done in combination with fluorescein angiography for a more complete visualization of retinal pathology. simultaneous examination of both retinal and choroidal circulation allows for identification of microaneurysms that are hyperfluorescent both on fluorescein angiography and indocyanine green angiography. such microaneurysms are sites of increased vascular leakage and represent a means for providing more effective laser treatment by targeting these areas directly with focal laser.

Eligibility criteria:
inclusion criteria: * meets criteria for clinically significant macular edema * microaneurysms hyperfluorescent exclusion criteria: * increase intraocular pressure * intraocular inflammation * retinal detachment
evolutive potential of embryos obtained from oocytes after luteal phase ovarian stimulation

Conditions: INFERTILITY; Fertility Preservation; Ovulation Induction; Vitrification; Oocyte Donation

Summary: the purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . this study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients


Eligibility criteria:
inclusion criteria: * premenopausal women, 18-35 years old, fsh levels \ 10 * regular cycles * bmi \< 28 * signed informed consent recipients: * infertile women eligible for oocytes donation * bmi \< 35 * signed informed consent form exclusion criteria: -polycystic ovarian syndrome, gonadotropins allergy recipients: * women eligible for oocytes donation * bmi \>35 * uncontrolled endocrine pathology

Keywords: ovarian stimulation luteal phase egg donors fertility preservation
safety and efficacy vagal nerve stimulation in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is a 12 week open label pilot study to determine the efficacy and safety of a surgically implanted, electrically active vagal nerve stimulation device in patients with active rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * adult-onset rheumatoid arthritis of at least six months duration as defined by the 2010 acr/eular classification criteria (aletaha, 2010) * male or female patients, 18-75 years of age, inclusive * functional status i, ii, or iii as classified according to the acr 1991 revised criteria (hochberg, 1992) * patients must have active disease as defined by at least 4 active tender or swollen joints and crp above 0.7 mg/dl, despite at least 3 months of treatment with methotrexate at a dose of up to 25 mg orally per week. * patients may have been previously treated with tnf antagonists, but must have failed by reason of inadequate safety, intolerance to side effects, or development of antibodies (i.e., secondary failures), and specifically cannot have failed on the basis of primary lack of efficacy * study amended to add a second cohort of up to 10 patients who have failed both a tnf antagonist and at least one other biological therapy having a non-tnf antagonist mechanism of action exclusion criteria: * history of unilateral or bilateral vagotomy * history of recurrent vaso-vagal syncope episodes * known obstructive sleep apnea * known history of cardiac rhythm disturbances, atrio-ventricular block of greater than first degree, or cardiac conduction pathway abnormalities other than isolated right bundle branch block or isolated left anterior fascicle block * significant pharyngeal dysfunction or swallowing difficulties * pre-existing clinically significant vocal cord damage or hoarseness * previously implanted electrically active medical devices (e.g., cardiac pacemakers, automatic implantable cardioverter-defibrillators) * asthma or chronic obstructive pulmonary disease not controlled by medications, or any other disease causing clinically significant dyspnea at time of screening * active peptic ulcer disease

Keywords: vagus nerve vagal nerve stimulation rheumatoid arthritis implantable medical device
platelet-rich plasma for meniscus repair

Conditions: Platelet-Rich Plasma; Knee Injuries; Meniscus Disorder

Summary: this study aims to evaluate the effect of platelet-rich plasma (prp) on meniscus injury by comparing the imaging and clinical outcomes between patients receiving prp with meniscus repair surgery and those receiving meniscus repair surgery only.

damage to meniscal tissue is challenging for orthopedic surgeons because of the absence of healing at the avascular zone. additionally, the accelerated degeneration of articular cartilage and increased rate of knee osteoarthritis that can occur following a meniscal injury. platelet-rich plasma (prp) is a fraction of plasma that contains platelets and multiple growth factors concentrated at high level. because activated platelets have the potential to release growth factors, prp has been clinically used to accelerate wound healing and tissue regeneration in orthopedic and oral surgery. several in vivo and in vitro studies have reported favorable outcomes of prp on meniscal repair; however, the clinical results varied between studies.this clinical trial will investigate the effect of prp on on meniscus injury. eligible patients will be randomly assigned to receive prp with meniscus repair surgery or to receive meniscus repair surgery only. the postoperative imaging and clinical outcomes will be compared and analyzed.

Eligibility criteria:
inclusion criteria: * age between 20 and 60 years * with diagnosis of meniscus injury * with indications of meniscus repair surgery exclusion criteria: * multiple ligaments injury * with prior history of knee surgery * cancer patients * pregnancy * patients who will not cooperate with one-year followup

Keywords: platelet-rich plasma meniscus knee injuries
indwelling urinary catheterization versus clean intermittent catheterization for the short-term management of hospitalized patients with transient acute urinary retention

Conditions: Urinary Retention

Summary: objective: acute urinary retention (aur) is a common problem in hospitalized patients. either indwelling urethral catheterization or clean intermittent catheterization (cic) can be the choice of treatment. in chronic urinary retention, most physicians prefer cic to chronic indwelling urethral catheter on the basis of the claim that the rate of catheter-associated urinary tract infection (cauti) is lower. method: the patients were randomized into indwelling urethral catheter and cic groups. the primary outcomes of the study were catheter-associated asymptomatic bacteriuria and cauti. the secondary outcomes were pain, hematuria, cloudy urine, and quality of life.

we queried the hospitalized patients in ramathibodi hospital who developed first-time aur from june 2014 to may 2015. patients under 18 years of age with a history of urinary retention, urinary tract infection, and poor compliance were excluded from this study. all the patients gave their written informed consents. the patients were randomly divided into two groups depending on the type of assigned intervention: cic and indwelling urethral catheter groups. all the patients were followed up after 2 weeks; urinalysis and urine culture were obtained at the time of aur and whenever the patients developed uti-associated symptoms. the patients with positive urine culture at the time of aur were excluded from the study.

Eligibility criteria:
inclusion criteria: * hospitalized patients in ramathibodi hospital who developed first-time aur from june 2014 to may 2015. exclusion criteria: * patients under 18 years of age * history of urinary retention * urinary tract infection * poor compliance

Keywords: urethral catheter clean intermittent catheterization uti pain quality of life hematuria cloudy urine
mdd poc study gsk372475 subjects depressive disease

Conditions: Depressive Disorder

Summary: to evaluate the efficacy, safety and tolerability of gsk372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.


Eligibility criteria:
inclusion criteria: * major depressive episode (mde) associated with major depressive disorder (dsm-iv-tr criteria) * duration of current episode is at least 12 weeks duration and less than 2 years * symptoms of decreased energy, pleasure, and interest * female subjects who agree to use acceptable methods of birth control throughout the study exclusion criteria: * current diagnosis of panic disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial * symptoms of mde better accounted for by another diagnosis * diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s). * started psychotherapy within 3 months prior to the screening * received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening * received psychoactive drugs within 4 weeks of randomization * positive urine drug screen or positive blood alcohol * suicidal risk or has had any previous suicide attempt, a family history of suicide attempt * positive pregnancy test * history of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition * failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants

Keywords: mdd flexible-dose major depressive disorder paroxetine gsk372475
an dose escalation study of bibf 1120 administered in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: maximum tolerated dose (mtd), safety, pharmacokinetics, efficacy of bibf 1120, pharmacodynamics


Eligibility criteria:
inclusion criteria: 1. patients with confirmed diagnosis of multiple myeloma, who did not respond to or relapsed after either anthracyclines and pulsed glucocorticoids or high-dose therapy and who are currently not eligible for transplant modalities. 2. age 18 years or older 3. life expectancy of at least six months 4. patients have to give written informed consent (which must be consistent with ich-gcp and local legislation) 5. eastern cooperative oncology group (ecog) performance score \<2. 6. recovery from all therapy-related toxicities from previous chemo-, immuno- or radiotherapies. exclusion criteria: 1. history of relevant surgical procedures during the last four weeks prior to treatment with the trial drug, or active ulcers, fractures or injuries with incomplete healing 2. active infectious disease 3. uncontrolled, severe hypertension 4. gastrointestinal disorders anticipated to interfere with the resorption of the study drug 5. serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol 6. absolute neutrophil count less than 1000 / mm³. 7. platelet count less than 30 000 / mm³ 8. conjugated bilirubin greater than 2 mg / dl (\> 34 μmol/l, si unit equivalent) 9. aspartate amino transferase (ast) and / or alanine amino transferase (alt) greater than three times the upper limit of normal 10. endogenous creatinine clearance (ecc) \<20 ml/min 11. women and men who are sexually active and unwilling to use a medically acceptable method of contraception 12. pregnancy or breastfeeding 13. treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) 14. patients unable to comply with the protocol 15. active alcohol or drug abuse
safety and efficacy study of intravenous uricase-peg 20

Conditions: Gout; Hyperuricemia

Summary: the purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of uricase-peg 20.

uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. in those which chronically elevated uric acid, gout may develop. in the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. uricase-peg 20 is a recombinant uricase conjugated with multiple peg molecules designed to prolong the half-life and decrease the immunogenicity of uricase. this study will characterize the safety, pharmacokinetics and pharmacodynamics of intravenous uricase-peg 20, the anticipated route of administration to be used in future clinical development in tumor lysis syndrome.

Eligibility criteria:
inclusion criteria: * serum uric acid \> 6 mg/dl (men) or \> 5 mg/dl (women) * clinical laboratory values within normal limits or not clinically significant * women should be menopausal or peri-menopausal exclusion criteria: * prior exposure to uricase * history of severe allergic reactions, or any allergy to peg or pegylated products * g6pd or catalase deficiency * medical condition that may interfere with ability to complete the study (e.g., uncontrolled diabetes or hypertension, congestive heart failure nyha class iii or iv, history of myocardial infarction, immunosuppression, pregnancy)
borderline resectable pancreatic cancer: gemcitabine/docetaxel and oxaliplatin based chemo/rt

Conditions: Pancreatic Cancer

Summary: this study is being conducted to find out what effects (good and bad) that a combination of treatment with chemotherapy, radiation therapy and surgery has on you and your pancreatic cancer. the chemotherapy drugs to be used: gemcitabine, docetaxel, oxaliplatin, 5-fu and alpha-interferon. the goal is to decrease the size of the tumor, so that removal by surgery can be performed. current treatments for this stage of pancreas cancer offer less than ideal results, with little opportunity for treatment with curative intent.

subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally measurable on ct. cancer must be considered locally advanced (not able to be treated surgically). subjects must not have received prior treatment for pancreatic cancer. subjects must not have received prior radiation therapy to the abdomen or pelvis (for any reason). subjects cannot be receiving immunosuppressive therapy (e.g. prednisone, methotrexate). eligible subjects will receive initial chemotherapy regimen to include eight cycles of gemcitabine and docetaxel. all subjects will be re-evaluated for surgery - if tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy of oxaliplatin, 5fu and alpha-interferon and radiation therapy; once subject has recovered from side effects of the chemo/radiation therapy, they will receive a final chemotherapy regimen of four cycles of gemcitabine and docetaxel. subjects who are not surgical candidates after eight cycles of chemotherapy will undergo an additional four cycles of gemcitabine and docetaxel followed by reassessment for surgery. if they are a surgical candidate, they will undergo surgery followed by chemo/radiation therapy regimen. if they are not a surgical candidate, they will undergo the chemo/radiation therapy regimen. subjects may be removed from the study treatment for the following reasons: * the investigator feels the subject is not benefitting from treatment * the subject chooses to discontinue for any reason * the subject experiences side effects which are considered to be unacceptable * the subject has an increase in the size of their tumor

Eligibility criteria:
inclusion criteria: * biopsy proven adenocarcinoma of the pancreas * tumor must be radiographically bidimensional by abdominal/pelvic ct * cancer must be locally advanced and not considered immediately treated by standard surgical procedure * no prior therapy for pancreas cancer exclusion criteria: * women who are pregnant or lactating * subjects who have received prior external beam radiation to the abdomen or pelvis * subjects receiving chronic immunosuppressive therapy (prednisone, methotrexate)

Keywords: pancreas cancer combined modality therapy